Ignite Creation Date:
2025-12-24 @ 3:50 PM
Ignite Modification Date:
2025-12-30 @ 1:59 AM
Study NCT ID:
NCT00004492
Status:
COMPLETED
Last Update Posted:
2015-03-25
First Post:
1999-10-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase I/II Randomized Study of Hydroxyurea With or Without Clotrimazole in Patients With Sickle Cell Anemia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000755', 'term': 'Anemia, Sickle Cell'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D035583', 'term': 'Rare Diseases'}], 'ancestors': [{'id': 'D000745', 'term': 'Anemia, Hemolytic, Congenital'}, {'id': 'D000743', 'term': 'Anemia, Hemolytic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006453', 'term': 'Hemoglobinopathies'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003022', 'term': 'Clotrimazole'}, {'id': 'D006918', 'term': 'Hydroxyurea'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D014508', 'term': 'Urea'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1999-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2001-01', 'completionDateStruct': {'date': '2001-09'}, 'lastUpdateSubmitDate': '2015-03-24', 'studyFirstSubmitDate': '1999-10-18', 'studyFirstSubmitQcDate': '1999-10-18', 'lastUpdatePostDateStruct': {'date': '2015-03-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '1999-10-19', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['genetic diseases and dysmorphic syndromes', 'hematologic disorders', 'rare disease', 'sickle cell anemia'], 'conditions': ['Sickle Cell Anemia']}, 'descriptionModule': {'briefSummary': 'OBJECTIVES:\n\nI. Compare the efficacy of hydroxyurea with or without clotrimazole in terms of limiting the severity of anemia and the rate of hemolysis in patients with sickle cell anemia.', 'detailedDescription': 'PROTOCOL OUTLINE: This is a randomized study. Patients are randomized to one of two treatment arms.\n\nArm I: Patients receive oral hydroxyurea and oral clotrimazole daily for 12 months.\n\nArm II: Patients receive oral hydroxyurea daily for 12 months. Patients are followed at 6 weeks.\n\nCompletion date provided represents the completion date of the grant per OOPD records'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'PROTOCOL ENTRY CRITERIA:\n\n--Disease Characteristics--\n\nDiagnosis of sickle cell anemia confirmed by hemoglobin electrophoresis\n\nReceived hydroxyurea for at least 6 months On a stable dose for at least 3 months Tolerating dose of at least 5 mg/kg/day\n\n--Prior/Concurrent Therapy--\n\nChemotherapy:\n\n* No other concurrent antisickling agent\n\nOther: No concurrent drug that may interact with or influence the metabolism of hydroxyurea or clotrimazole\n\n--Patient Characteristics--\n\nHematopoietic: WBC at least 4000/mm3 Platelet count at least 150,000/mm3 Hemoglobin less than 11 g/dL\n\nHepatic: AST/ALT no greater than 100 units/L\n\nRenal: Creatinine no greater than 1.5 mg/dL\n\nOther:\n\n* Not pregnant or nursing\n* Fertile patients must use effective contraception\n* No prior adverse reaction to hydroxyurea or clotrimazole\n* No recent or progressive neurologic dysfunction'}, 'identificationModule': {'nctId': 'NCT00004492', 'briefTitle': 'Phase I/II Randomized Study of Hydroxyurea With or Without Clotrimazole in Patients With Sickle Cell Anemia', 'organization': {'class': 'FED', 'fullName': 'FDA Office of Orphan Products Development'}, 'orgStudyIdInfo': {'id': '199/14273'}, 'secondaryIdInfos': [{'id': 'UNCCH-FDR001531'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'clotrimazole', 'type': 'DRUG'}, {'name': 'hydroxyurea', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '27599-7070', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina School of Medicine', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}], 'overallOfficials': [{'name': 'Eugene Paul Orringer', 'role': 'STUDY_CHAIR', 'affiliation': 'University of North Carolina'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of North Carolina', 'class': 'OTHER'}}}}